CDSCO License for Cardiopulmonary bypass vascular catheter, cannula, or tubing
Medical Device Information
Intended Use
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
Comprehensive CDSCO Licensing Guide for Cardiopulmonary Bypass Vascular Catheters (Class B Medical Device)
Navigating the regulatory landscape in India for medical devices such as cardiopulmonary bypass vascular catheters, cannulas, or tubing can be complex. These devices play a critical role in cardiovascular surgeries by enabling vessel cannulation, perfusion of coronary arteries, and connecting to oxygenators. Given their vital function, the Central Drugs Standard Control Organization (CDSCO) has classified them as Class B under the cardiovascular category, necessitating adherence to specific regulatory protocols.
With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we bring you a detailed roadmap tailored specifically for this device type. This guide covers regulatory requirements, timelines, costs, and practical steps to streamline your market entry.
CDSCO Regulatory Framework for Cardiopulmonary Bypass Vascular Catheters
Since July 26, 2021, these vascular catheters fall under Notification 29/Misc./03/2020-DC (159), mandating compliance with CDSCO’s medical device regulations. The licensing framework for Class B devices involves obtaining the MD5 manufacturing license, issued by the State Licensing Authority, ensuring that the manufacturing process meets quality and safety standards.
The regulatory process includes obtaining a Test License (Form MD13), product testing by government-approved labs, documentation preparation, notified body audits, and final license issuance.
Risk Classification and License Requirements for Class B Cardiovascular Devices
Cardiopulmonary bypass vascular catheters are categorized as Class B (Low Moderate Risk) devices. This classification affects how the device is reviewed and licensed:
- License Type: MD5 (Manufacturing License for Class A and B devices)
- Authority: State Licensing Authority
- Application Form: MD3 for manufacturing license
- Test License: Required (Form MD13) before applying for MD5
Understanding this classification helps in preparing the correct documentation and anticipating regulatory timelines.
Manufacturing License Process (MD5) for Cardiopulmonary Bypass Vascular Catheters
The MD5 licensing process involves several well-defined steps:
Test License Application (Form MD13): Submit your test license application through the CDSCO MD Online Portal. This allows initial product testing.
Product Testing: Get your cardiopulmonary bypass vascular catheter tested at government-approved labs listed on the CDSCO portal. Testing typically takes 4-6 weeks.
Documentation Preparation: Prepare all required technical and quality documents, including Device Master File and Plant Master File.
Manufacturing License Application: Apply for the MD5 license using Form MD3.
Audit by Notified Body: Engage a notified body from the official list for manufacturing site audit.
Query Resolution: Address any queries raised during the audit or by the licensing authority.
Grant of License: Upon satisfactory review, the State Licensing Authority issues your MD5 license (Form MD5).
Typically, the entire MD5 process takes 3 to 4 months including testing and audit.
Manufacturing License Documents Required for Cardiopulmonary Bypass Vascular Catheters
To ensure smooth processing, prepare the following documents meticulously:
- Company Constitution or Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification Documents (e.g., biomedical engineers, quality managers)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed technical specifications and design (see our Device Master File guide)
- Plant Master File (PMF): Details about manufacturing facility aligned with GMP standards (Plant Master File guide)
- Essential Principles Checklist
- Risk Management File demonstrating compliance with ISO 14971 (Risk Management insights)
- Test Reports from government-approved laboratories (Testing Laboratories)
- Label and Packaging Details
- Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certification
Accurate and complete documentation reduces back-and-forth queries and expedites approval.
Import License Process (MD15) for Cardiopulmonary Bypass Vascular Catheters
For importers, the CDSCO mandates obtaining an MD15 import license from the Central Licensing Authority. The process is as follows:
Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
Query Resolution: Respond promptly to any department queries.
License Grant: After successful verification, the MD15 license is issued.
The import license process typically takes 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution and incorporation documents
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 4 to 6 weeks |
| Document Preparation | 2 to 4 weeks |
| Manufacturing License (MD5) | 1 to 1.5 months |
| Total Time (MD5 License) | Approx. 3 to 4 months |
For import licenses (MD15), expect approximately 5 to 6 months.
Government Fees and Costs
The official fees for MD5 licensing for Class B devices are:
- Application Fee: Rs. 5,000 per application
- Per Product Fee: Rs. 500 per product
Additional costs may include:
- Testing laboratory fees (varies by test scope)
- Notified body audit fees (consult the Notified Bodies List)
- Preparation of technical documentation and consulting fees
Budgeting accurately for these fees and costs is crucial to avoid delays.
Common Challenges and Solutions in CDSCO Licensing for Cardiopulmonary Bypass Catheters
Challenge 1: Incomplete Documentation
Solution: Use detailed checklists and consult regulatory experts to ensure all documents meet CDSCO standards.
Challenge 2: Delays in Product Testing
Solution: Book slots well in advance with government-approved testing labs and ensure your samples meet submission criteria.
Challenge 3: Non-compliance during Audit
Solution: Conduct internal pre-audit reviews, train staff, and maintain quality systems aligned with ISO 13485.
Challenge 4: Query Resolution Delays
Solution: Assign dedicated personnel to handle CDSCO queries promptly and provide clear, detailed responses.
Expert Consultation and Support
Given the technical and regulatory complexities, partnering with an experienced regulatory consultant can significantly smoothen the licensing journey. With our 25+ years of expertise and successful track record of helping 500+ companies, we provide:
- End-to-end application preparation
- Liaison with CDSCO and notified bodies
- Customized training on quality systems and risk management
- Guidance on audit readiness and query management
Our comprehensive MD5 License Guide details step-by-step support.
Getting Started with Your CDSCO License Application for Cardiopulmonary Bypass Vascular Catheters
To initiate your licensing process:
Identify Your Licensing Authority: For manufacturing Class B devices, approach your respective State Licensing Authority.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process.
Prepare and Submit Test License Application (MD13): This is your first regulatory step.
Engage Accredited Testing Labs: Schedule product tests early to avoid delays.
Start Compiling Documentation: Begin assembling your Device Master File and Plant Master File concurrently.
Plan for Notified Body Audit: Identify and engage a notified body from the official list.
Consult Experts: Leverage expert advice to ensure compliance and anticipate regulatory queries.
By taking these actionable steps, you position your cardiopulmonary bypass vascular catheter device for timely and successful CDSCO license approval, enabling you to access the growing Indian cardiovascular device market with confidence.
